Cardiac Implantable Electronic Device (CIED)NCT07530107
Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.
An observational study of Cardiac Implantable Electronic Device (CIED), run by IRCCS Ospedale San Raffaele.
Trial summary
The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Implantable Electronic Device (CIED)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients underwent TLE for lead and pocket infection
Who may be able to join
- Patients ≥ 18 years.
- Patients who underwent explantation of a single-chamber, dual-chamber, or biventricular pacemaker, or an intracardiac defibrillator, due to pocket infection, lead-related infection, or endocarditis at San Raffaele Hospital between January 2004 and November 2020.
Who cannot join
- Lack of active status of follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long Term Outcomes of Cardiac Implantable Electronic Device Infections and Transvenous Lead Extraction: a Single Center Retrospective
The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major clinical adverse outcomes
Cardiovascular mortality
Measured: 1 year and 5 years follow up
Major clinical adverse outcomes
cardiovascular rehospitalization
Measured: 1 year and 5 years follow up
Major clinical adverse outcomes
all-cause mortality
Measured: 1 year and 5 years follow up
Secondary outcomes (1)
need of re-implantation of CIED for patients who underwent TLE
Eventual re-implantation after TLE, during the sane or a following hospitalization.
Timing between TLE and re-implantation
Measured: discharge, 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Implantable Electronic Device (CIED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Gulletta, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530107
- Sponsor's protocol ID
- CIED EXTRACTION
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011 Nov 14;171(20):1821-8. doi: 10.1001/archinternmed.2011.441. Epub 2011 Sep 12.
PubMed 21911623Vaidya VR, Alraies MC, Kelli HM, Patel N, Nairooz R, Maher J, et al. Transvenous lead extraction: predictors of mortality and outcomes in over 10,000 procedures. Heart Rhythm. 2021;18(7):1099-1105. doi:10.1016/j.hrthm.2021.03.013
Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):252-7. doi: 10.1161/CIRCEP.111.965277. Epub 2012 Feb 23.
PubMed 22362891Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, Romano SL, Maggioni AP, Andarala M, Auricchio A, Kuck KH, Blomstrom-Lundqvist C; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. doi: 10.1093/eurheartj/ehx080.
PubMed 28369414
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Cardiac Implantable Electronic Device Infections and Transvenous Lead Extraction: a Single Center Retrospective
- ClinicalTrials.gov ID
- NCT07530107
- Acronym / sponsor ID
- CIED EXTRACTION
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients underwent TLE for lead and pocket infection
Key inclusion criteria (2 listed)
- Patients ≥ 18 years.
- Patients who underwent explantation of a single-chamber, dual-chamber, or biventricular pacemaker, or an intracardiac defibrillator, due to pocket infection, lead-related infection, or endocarditis at San Raffaele Hospital between January 2004 and November 2020.
Key exclusion criteria (1 listed)
- Lack of active status of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major clinical adverse outcomes
Time frame: 1 year and 5 years follow up
Cardiovascular mortality
Major clinical adverse outcomes
Time frame: 1 year and 5 years follow up
cardiovascular rehospitalization
Major clinical adverse outcomes
Time frame: 1 year and 5 years follow up
all-cause mortality
1 secondary outcome
need of re-implantation of CIED for patients who underwent TLE
Time frame: discharge, 1 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 21911623Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011 Nov 14;171(20):1821-8. doi: 10.1001/archinternmed.2011.441. Epub 2011 Sep 12.
- BackgroundVaidya VR, Alraies MC, Kelli HM, Patel N, Nairooz R, Maher J, et al. Transvenous lead extraction: predictors of mortality and outcomes in over 10,000 procedures. Heart Rhythm. 2021;18(7):1099-1105. doi:10.1016/j.hrthm.2021.03.013
- Background: PubMed 22362891Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):252-7. doi: 10.1161/CIRCEP.111.965277. Epub 2012 Feb 23.
- Background: PubMed 28369414Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, Romano SL, Maggioni AP, Andarala M, Auricchio A, Kuck KH, Blomstrom-Lundqvist C; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. doi: 10.1093/eurheartj/ehx080.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Implantable Electronic Device (CIED), run by IRCCS Ospedale San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SImone Gulletta, MD (02 2643 7484, gulletta.simone@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major clinical adverse outcomes (time frame: 1 year and 5 years follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.